MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-10 for T2100 manufactured by Ge Medical Systems Information Technologies, Inc..
[96840148]
Patient Sequence No: 1, Text Type: N, H10
[96840149]
Treadmill started at inappropriately fast rate. Patient lost footing and slid onto knees and top of feet. Doctor present. No injury noted upon assessment. Patient assisted to stretcher. Treadmill test order changed to chemical stress instead of walking. Manufacturer response for treadmill, ge (per site reporter): ge biomed will come assess the treadmill. As of now, the equipment has been removed from service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7178075 |
| MDR Report Key | 7178075 |
| Date Received | 2018-01-10 |
| Date of Report | 2018-01-04 |
| Date of Event | 2017-12-15 |
| Report Date | 2018-01-04 |
| Date Reported to FDA | 2018-01-04 |
| Date Reported to Mfgr | 2018-01-04 |
| Date Added to Maude | 2018-01-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T2100 |
| Generic Name | TREADMILL, POWERED |
| Product Code | IOL |
| Date Received | 2018-01-10 |
| Model Number | T2100 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
| Manufacturer Address | 8200 W TOWER AVE MILWAUKEE, WI 53223 WI 53223 US 53223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-10 |